ZEVALIN
Zevalin (ibritumomab tiuxetan) is a CD20-directed radiotherapeutic antibody indicated for the treatment of adult patients with specific forms of B-cell non-Hodgkin's lymphoma (NHL). It is used to treat patients with relapsed or refractory, low-grade or follicular B-cell NHL. Additionally, the drug is indicated for patients with previously untreated follicular NHL who have achieved a partial or complete response following first-line chemotherapy.
How ZEVALIN Works
Ibritumomab tiuxetan targets the CD20 antigen, a protein expressed on the surface of more than 90% of B-cell non-Hodgkin’s lymphomas and mature B lymphocytes. The antibody is covalently linked to a chelate that binds the radioisotope Y-90, which delivers beta radiation to the site of the tumor. This beta emission induces cellular damage by forming free radicals within the target cells and neighboring cells.
Details
- Status
- Prescription
- First Approved
- 2002-02-19
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZEVALIN Approval History
What ZEVALIN Treats
1 indicationsZEVALIN is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Hodgkin's Lymphoma
ZEVALIN Boxed Warning
SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion ...
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion [ see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ] . Discontinue rituximab and Y-90 Zevalin infusions in patients who develop severe infusion reactions. Prolonged and Severe Cytopenias: Y-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Do not administer Y-90 Zevalin to patients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve [ see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 ) ]. Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the Zevalin therapeutic regimen. Discontinue rituximab and Y-90 Zevalin infusions in patients experiencing severe cutaneous or mucocutaneous reactions [ see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 ) ]. Dosing: The dose of Y-90 Zevalin should not exceed 32 mCi (1184 MBq) [ see Dosage and Administration ( 2.2 ) ]. WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS See full prescribing information for complete boxed warning Serious Infusion Reactions, some fatal, may occur within 24 hours of rituximab infusion. ( 5.1 ) Prolonged and Severe Cytopenias occur in most patients. ( 5.2 ) Severe Cutaneous and Mucocutaneous Reactions, some fatal, reported with Zevalin therapeutic regimen. ( 5.3 , 6.2 ) Do not exceed 32 mCi (1184 MBq) of Y-90 Zevalin. ( 2.2 )
ZEVALIN Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
ZEVALIN Competitors
Pro10 other drugs also target CD20. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD20). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZEVALIN FDA Label Details
ProIndications & Usage
FDA Label (PDF)Zevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with: relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) . previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy . 1.1 Relapsed or Refractory, Low-grade or Follicular NHL Zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). 1.2 Previously Untreated Follicular NHL Ze...
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated w...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.